BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIPER2 X-TAB POLYAXIAL SCREW DRIVER

    MDR report key: 3111078 · Received May 14, 2013

    Report

    Report Number
    1526439-2013-17022
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 28, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DRIVER AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DRIVER FOUND THAT THE MOST DISTAL PORTION OF THE TIP HAD BROKEN OFF FROM THE INSTRUMENT. THE BROKEN TIP WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DHR FOUND NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF TIP BREAKAGE. HOWEVER, A CAPA WAS IMPLEMENTED WHICH ADDRESSED TIP BREAKAGE THROUGH DESIGN MODIFICATION AND MATERIAL CHANGE. TESTING ON PRODUCTION LEVEL INSTRUMENTS HAD DETERMINED THAT TIP BREAKAGE WAS THE RESULT OF A BRITTLE FRACTURE OF THE MATERIAL. THIS PRODUCTION LOT WAS MANUFACTURED PRIOR TO THOSE CHANGES. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT INTRA-OPERATIVELY IT WAS NOTICED THAT THE TIP HAD BROKEN OFF FROM THE DRIVER. ANOTHER DRIVER WAS USED AND THE PROCEDURE WAS COMPLETED WITHOUT DELAY. THE AFFILIATE REPORTS THAT IT IS UNLIKELY THAT THE BROKEN TIP REMAINS IN THE PATIENT. HOWEVER, ITS LOCATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213532 VIPER2 X-TAB POLYAXIAL SCREW DRIVER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE MI19980

    Patients

    Seq Age Sex Outcome Treatment
    1